Senior QA for QC Specialist (Principal level)
FUJIFILM Biotechnologies · Hillerød, Capital Region of Denmark, Denmark
Biotechnology Research · 1,001-5,000 employees
About the role
Provide quality assurance support to the QC laboratory, focusing on the review and approval of method technology transfer documents and related quality topics. Ensure compliance through the assessment of changes and deviations while acting as a quality partner for internal stakeholders.
What they look for
Requirements
Requires over 10 years of relevant experience in biologics manufacturing or a related educational background. Candidates should be well-versed in GxP guidance and quality systems with a proactive, collaborative mindset.
Full description
Join our QA for QC team at FUJIFILM Biotechnologies in Hillerød as a Senior QA for QC Specialist, supporting our QC laboratory in this newly created position. As our production site grows, QC expands, which requires increased quality oversight.
We are looking for the right Senior QA for QC Specialist who would like to be part of a positive, engaged, and supportive team.
Currently, the team consists of 13 people and is part of a larger QA organization that provides quality support to drug substance manufacturing, drug product filling, and Assembly, Label and Pack. QA for QC is a dynamic team with close collaboration across multiple internal stakeholders and QA colleagues.
As a Senior QA for QC Specialist with over 10 years of relevant experience, your responsibilities will vary based on your qualifications and interests. These include reviewing and approving method technology transfer documents; supporting related quality topics such as method tech transfer discussions, changes, and deviations; as well as handling ad hoc assignments. Additionally, you will actively engage with QC and QC-AD to enhance compliance and ensure quality oversight in general.
Primary Responsibilities
- Provide QA support to QC, including QC-AD
- Review and approve method technology transfer documents and support related quality topics
- Review and approve QC-related documentation
- Assess and approve changes and deviations
- Ensure procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported
- Act as a quality partner by providing guidance, training, and ad hoc support to stakeholders
- Represent QA for QC on assigned projects related to QC
- Contribute to local and potential future global alignment tasks within QA for QC
- Maintain internal training levels and stay up to date on cGMPs and regulatory requirements, as well as on global procedures, guidelines, policies, frameworks, and specifications
Qualifications / Skills
- Collaborative mindset with a willingness to integrate into the team and organization
- Well-versed in GxP guidance and knowledgeable about quality systems
- Ability to work in a highly dynamic environment and thrive while “building the road as we go”
- Self-driven, proactive, with excellent communication skills and strong organizational abilities
- 10+ years of work experience or an educational background that enables understanding of the complexity of manufacturing biologics
- Preferably experience overseeing the quality of method tech transfers
- Experience with deviations and changes
Education
The right mindset, strong deliverables, and practical experience are key. Educational background comes second but could be within the following areas (though not a prerequisite): Bachelor’s or Master’s degree in a natural science, e.g., Pharmacy, Biotechnology, Biology, Engineering, or similar.
If you do not meet all the above criteria but believe you can contribute and still find the position interesting, please submit your application.
